With one heart failure nod already in the books, Eli Lilly and Boehringer Ingelheim’s diabetes blockbuster Jardiance just racked up another key approval—opening the door to a much wider range of patients.
The U.S. FDA on Thursday blessed Lilly and Boehringer’s Jardiance with a label expansion to curb the risk of cardiovascular death and hospitalization in adults with heart failure. The move comes after the partners in November sent off an FDA application for the med to treat adults with heart failure independent of left ventricular ejection fraction.
The green light builds on an approval to reduce the risk of hospitalization and death in patients with heart failure and low ejection fraction. Thursday’s nod makes Jardiance the only med cleared to improve outcomes in all heart failure patients, no matter their ejection fraction status.
For patients with heart failure with reduced ejection fraction (HFrEF)—where Jardiance bagged an approval in August—the heart muscle doesn’t contract properly. For patients with heart failure with preserved ejection fraction (HFpEF)—included under Thursday’s approval—the muscle contracts properly, but the ventricles don’t relax. Both conditions affect the heart’s ability to pump enough blood.
“Adding to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance, this approval represents an opportunity to help fill an urgent need for adults across the full spectrum of heart failure,” Jeff Emmick, M.D., Ph.D., vice president of product development at Eli Lilly, said in an emailed statement.
Jardiance is also approved to improve glucose control in adults with type 2 diabetes, as well as to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
The FDA based its decision on data from Jardiance’s phase 3 Emperor-Preserved trial, which looked at the drug’s safety and heart failure performance in nearly 3,000 patients. The study’s primary endpoint was time to death from cardiovascular causes or need for hospitalization for heart failure, the FDA noted in its release.
“Heart failure represents a significant, growing disease burden in the U.S., with more than 8 million cases expected by 2030,” Mohamed Eid, M.D., M.P.H., M.H.A., vice president of clinical development and medical affairs for cardio-metabolism and respiratory medicine at Boehringer Ingelheim, said via email. “With today’s approval of a breakthrough treatment option for a widely underserved group of people who have heart failure, we take a step closer toward our goal of transforming how we treat this debilitating disease.”
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Among patients who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared with 17% of patients in the placebo cohort. This benefit mostly came from fewer patients being hospitalized for heart failure, the regulator noted.
Thursday’s nod gives Jardiance an edge in a highly competitive heart failure arena, where AstraZeneca’s Farxiga, Novartis’ Entresto and Merck and Bayer’s Verquvo are already jockeying for share.
Jardiance, for its part, won its first heart failure nod in HFrEF a little over a year after AstraZeneca’s rival SGLT2 drug, Farxiga, nabbed its own HFrEF green light. Meanwhile, Merck and Bayer’s Verquvo won approval last January to treat certain high-risk HFrEF patients.
